Trial Outcomes & Findings for A Study of 2 Doses of MAP0010 in Adult Asthmatics (NCT NCT00554970)
NCT ID: NCT00554970
Last Updated: 2014-01-09
Results Overview
The maximum concentration (Cmax) is the highest concentration of a drug measured in the plasma. Plasma is the clear portion of the blood. The Cmax of Budesonide is reported in picograms per milliliter (pg/ml).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
32 participants
Primary outcome timeframe
Day 1 hour 12
Results posted on
2014-01-09
Participant Flow
This is a 4-treatment, 2-period crossover study. Subjects were randomized to receive either Treatments 1 (MAP0010 low dose) and 2 (Pulmicort Respules® 0.25mg) or 3 (MAP0010 high dose) and 4 (Pulmicort Respules® 0.5mg). Subjects were randomized to the following sequences: Tx 1 then Tx 2, Tx 2 then Tx 1, Tx 3 then Tx 4, or Tx 4 then Tx 3
Participant milestones
| Measure |
Treatment 1 Then Treatment 2
Subjects received Treatment 1 in period 1 followed by a 7 day washout period and then Treatment 2 in period 2. Treatment 1 was a single dose of MAP0010 low dose delivered by nebulization twice daily for 7 days as per protocol. Treatment 2 was a single dose of Pulmicort Respules® 0.25mg dose delivered by nebulization twice daily for 7 days as per protocol.
|
Treatment 2 Then Treatment 1
Subjects received Treatment 2 in period 1 followed by a 7 day washout period and then Treatment 1 in period 2. Treatment 1 was a single dose of MAP0010 low dose delivered by nebulization twice daily for 7 days as per protocol. Treatment 2 was a single dose of Pulmicort Respules® 0.25mg dose delivered by nebulization twice daily for 7 days as per protocol.
|
Treatment 3 Then Treatment 4
Subjects received Treatment 3 in period 1 followed by a 7 day washout period and then Treatment 4 in period 2. Treatment 3 was a single dose of MAP0010 high dose delivered by nebulization twice daily for 7 days as per protocol. Treatment 4 was a single dose of Pulmicort Respules® 0.5mg dose delivered by nebulization twice daily for 7 days as per protocol.
|
Treatment 4 Then Treatment 3
Subjects received Treatment 4 in period 1 followed by a 7 day washout period and then Treatment 3 in period 2. Treatment 3 was a single dose of MAP0010 high dose delivered by nebulization twice daily for 7 days as per protocol. Treatment 4 was a single dose of Pulmicort Respules® 0.5mg dose delivered by nebulization twice daily for 7 days as per protocol.
|
|---|---|---|---|---|
|
Period 1
STARTED
|
8
|
8
|
8
|
8
|
|
Period 1
COMPLETED
|
7
|
8
|
8
|
8
|
|
Period 1
NOT COMPLETED
|
1
|
0
|
0
|
0
|
|
Period 2
STARTED
|
7
|
8
|
8
|
8
|
|
Period 2
COMPLETED
|
7
|
8
|
7
|
8
|
|
Period 2
NOT COMPLETED
|
0
|
0
|
1
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study of 2 Doses of MAP0010 in Adult Asthmatics
Baseline characteristics by cohort
| Measure |
Treatment 1 Then Treatment 2
n=8 Participants
Subjects received Treatment 1 in period 1 followed by a 7 day washout period and then Treatment 2 in period 2. Treatment 1 was a single dose of MAP0010 low dose delivered by nebulization twice daily for 7 days as per protocol. Treatment 2 was a single dose of Pulmicort Respules® 0.25mg dose delivered by nebulization twice daily for 7 days as per protocol.
|
Treatment 2, Then Treatment 1
n=8 Participants
Subjects received Treatment 2 in period 1 followed by a 7 day washout period and then Treatment 1 in period 2. Treatment 1 was a single dose of MAP0010 low dose delivered by nebulization twice daily for 7 days as per protocol. Treatment 2 was a single dose of Pulmicort Respules® 0.25mg dose delivered by nebulization twice daily for 7 days as per protocol.
|
Treatment 3 Then Treatment 4
n=8 Participants
Subjects received Treatment 3 in period 1 followed by a 7 day washout period and then Treatment 4 in period 2. Treatment 3 was a single dose of MAP0010 high dose delivered by nebulization twice daily for 7 days as per protocol. Treatment 4 was a single dose of Pulmicort Respules® 0.5mg dose delivered by nebulization twice daily for 7 days as per protocol.
|
Treatment 4 Then Treatment 3
n=8 Participants
Subjects received Treatment 4 in period 1 followed by a 7 day washout period and then Treatment 3 in period 2. Treatment 3 was a single dose of MAP0010 high dose delivered by nebulization twice daily for 7 days as per protocol. Treatment 4 was a single dose of Pulmicort Respules® 0.5mg dose delivered by nebulization twice daily for 7 days as per protocol.
|
Total
n=32 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
27.4 years
STANDARD_DEVIATION 8.9 • n=5 Participants
|
30.4 years
STANDARD_DEVIATION 7.2 • n=7 Participants
|
30.0 years
STANDARD_DEVIATION 8.3 • n=5 Participants
|
29.1 years
STANDARD_DEVIATION 6.9 • n=4 Participants
|
29.2 years
STANDARD_DEVIATION 7.6 • n=21 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
19 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
13 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Day 1 hour 12Population: Patients with available data at specified time points are included in the analysis population.
The maximum concentration (Cmax) is the highest concentration of a drug measured in the plasma. Plasma is the clear portion of the blood. The Cmax of Budesonide is reported in picograms per milliliter (pg/ml).
Outcome measures
| Measure |
MAP0010 High Dose
n=16 Participants
a single dose of MAP0010 high dose delivered by nebulization twice daily for 7 days as per protocol
|
Pulmicort Respules® 0.50 mg
n=16 Participants
a single dose of Pulmicort Respules® 0.5mg dose delivered by nebulization twice daily for 7 days as per protocol
|
MAP0010 Low Dose
n=16 Participants
a single dose of MAP0010 low dose delivered by nebulization twice daily for 7 days as per protocol
|
Pulmicort Respules® 0.25 mg
n=15 Participants
a single dose of Pulmicort Respules® 0.25mg dose delivered by nebulization twice daily for 7 days as per protocol
|
|---|---|---|---|---|
|
Cmax of Budesonide on Day 1 After Administration of MAP0010 Low Dose, MAP0010 High Dose, Pulmicort Respules® 0.25mg, and Pulmicort Respules® 0.5mg
|
250 pg/ml
Standard Deviation 161
|
365 pg/ml
Standard Deviation 203
|
168 pg/ml
Standard Deviation 130
|
197 pg/ml
Standard Deviation 102
|
PRIMARY outcome
Timeframe: Day 8 hour 12Population: Patients with available data at specified time points are included in the analysis population.
The maximum concentration (Cmax) is the highest concentration of a drug measured in the plasma. Plasma is the clear portion of the blood. The Cmax of Budesonide is reported in picograms per milliliter (pg/ml).
Outcome measures
| Measure |
MAP0010 High Dose
n=16 Participants
a single dose of MAP0010 high dose delivered by nebulization twice daily for 7 days as per protocol
|
Pulmicort Respules® 0.50 mg
n=15 Participants
a single dose of Pulmicort Respules® 0.5mg dose delivered by nebulization twice daily for 7 days as per protocol
|
MAP0010 Low Dose
n=16 Participants
a single dose of MAP0010 low dose delivered by nebulization twice daily for 7 days as per protocol
|
Pulmicort Respules® 0.25 mg
n=15 Participants
a single dose of Pulmicort Respules® 0.25mg dose delivered by nebulization twice daily for 7 days as per protocol
|
|---|---|---|---|---|
|
Cmax of Budesonide on Day 8 After Administration of MAP0010 Low Dose, MAP0010 High Dose, Pulmicort Respules® 0.25mg, and Pulmicort Respules® 0.5mg
|
528 pg/ml
Standard Deviation 257
|
530 pg/ml
Standard Deviation 334
|
366 pg/ml
Standard Deviation 262
|
315 pg/ml
Standard Deviation 206
|
PRIMARY outcome
Timeframe: Day 1 hour 12Population: Patients with available data at specified time points are included in the analysis population.
The AUC(0-inf) is the area under the plot of plasma concentration of drug against time after drug administration. Budesonide AUC(0-inf) is reported in picograms times minutes per milliliter (pg\*min/ml).
Outcome measures
| Measure |
MAP0010 High Dose
n=14 Participants
a single dose of MAP0010 high dose delivered by nebulization twice daily for 7 days as per protocol
|
Pulmicort Respules® 0.50 mg
n=15 Participants
a single dose of Pulmicort Respules® 0.5mg dose delivered by nebulization twice daily for 7 days as per protocol
|
MAP0010 Low Dose
n=16 Participants
a single dose of MAP0010 low dose delivered by nebulization twice daily for 7 days as per protocol
|
Pulmicort Respules® 0.25 mg
n=13 Participants
a single dose of Pulmicort Respules® 0.25mg dose delivered by nebulization twice daily for 7 days as per protocol
|
|---|---|---|---|---|
|
AUC(0-inf) of Budesonide on Day 1 After Administration of MAP0010 Low Dose, MAP0010 High Dose, Pulmicort Respules® 0.25mg, and Pulmicort Respules® 0.5mg
|
19400 pg*min/ml
Standard Deviation 7280
|
55900 pg*min/ml
Standard Deviation 19800
|
10300 pg*min/ml
Standard Deviation 4620
|
26900 pg*min/ml
Standard Deviation 7420
|
PRIMARY outcome
Timeframe: Day 8 hour 12Population: Patients with available data at specified time points are included in the analysis population.
The AUC(0-inf) is the area under the plot of plasma concentration of drug against time after drug administration. Budesonide AUC(0-inf) is reported in picograms times minutes per milliliter (pg\*min/ml).
Outcome measures
| Measure |
MAP0010 High Dose
n=14 Participants
a single dose of MAP0010 high dose delivered by nebulization twice daily for 7 days as per protocol
|
Pulmicort Respules® 0.50 mg
n=14 Participants
a single dose of Pulmicort Respules® 0.5mg dose delivered by nebulization twice daily for 7 days as per protocol
|
MAP0010 Low Dose
n=16 Participants
a single dose of MAP0010 low dose delivered by nebulization twice daily for 7 days as per protocol
|
Pulmicort Respules® 0.25 mg
n=14 Participants
a single dose of Pulmicort Respules® 0.25mg dose delivered by nebulization twice daily for 7 days as per protocol
|
|---|---|---|---|---|
|
AUC(0-inf) of Budesonide on Day 8 After Administration of MAP0010 Low Dose, MAP0010 High Dose, Pulmicort Respules® 0.25mg, and Pulmicort Respules® 0.5mg
|
58700 pg*min/ml
Standard Deviation 25700
|
90100 pg*min/ml
Standard Deviation 38200
|
35500 pg*min/ml
Standard Deviation 15000
|
45200 pg*min/ml
Standard Deviation 19500
|
PRIMARY outcome
Timeframe: Day 1 hour 12Population: Patients with available data at specified time points are included in the analysis population.
Half-life (t1/2) is the time for the drug to decrease to half of its maximum concentration. Budesonide t1/2 is reported in minutes.
Outcome measures
| Measure |
MAP0010 High Dose
n=14 Participants
a single dose of MAP0010 high dose delivered by nebulization twice daily for 7 days as per protocol
|
Pulmicort Respules® 0.50 mg
n=15 Participants
a single dose of Pulmicort Respules® 0.5mg dose delivered by nebulization twice daily for 7 days as per protocol
|
MAP0010 Low Dose
n=16 Participants
a single dose of MAP0010 low dose delivered by nebulization twice daily for 7 days as per protocol
|
Pulmicort Respules® 0.25 mg
n=13 Participants
a single dose of Pulmicort Respules® 0.25mg dose delivered by nebulization twice daily for 7 days as per protocol
|
|---|---|---|---|---|
|
Half-life (t1/2) of Budesonide on Day 1 After Administration of MAP0010 Low Dose, MAP0010 High Dose, Pulmicort Respules® 0.25mg, and Pulmicort Respules® 0.5mg
|
168 min
Standard Deviation 95.7
|
207 min
Standard Deviation 110
|
112 min
Standard Deviation 49.0
|
179 min
Standard Deviation 75.8
|
PRIMARY outcome
Timeframe: Day 8 hour 12Population: Patients with available data at specified time points are included in the analysis population.
Half-life (t1/2) is the time for the drug to decrease to half of its maximum concentration. Budesonide t1/2 is reported in minutes.
Outcome measures
| Measure |
MAP0010 High Dose
n=14 Participants
a single dose of MAP0010 high dose delivered by nebulization twice daily for 7 days as per protocol
|
Pulmicort Respules® 0.50 mg
n=14 Participants
a single dose of Pulmicort Respules® 0.5mg dose delivered by nebulization twice daily for 7 days as per protocol
|
MAP0010 Low Dose
n=16 Participants
a single dose of MAP0010 low dose delivered by nebulization twice daily for 7 days as per protocol
|
Pulmicort Respules® 0.25 mg
n=14 Participants
a single dose of Pulmicort Respules® 0.25mg dose delivered by nebulization twice daily for 7 days as per protocol
|
|---|---|---|---|---|
|
Half-life (t1/2) of Budesonide on Day 8 After Administration of MAP0010 Low Dose, MAP0010 High Dose, Pulmicort Respules® 0.25mg, and Pulmicort Respules® 0.5mg
|
193 min
Standard Deviation 67.2
|
192 min
Standard Deviation 66.3
|
248 min
Standard Deviation 192
|
230 min
Standard Deviation 130
|
Adverse Events
Treatment 1 Then Treatment 2
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Treatment 2, Then Treatment 1
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Treatment 3 Then Treatment 4
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Treatment 4 Then Treatment 3
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Treatment 1 Then Treatment 2
n=8 participants at risk
Subjects received Treatment 1 in period 1 followed by a 7 day washout period and then Treatment 2 in period 2. Treatment 1 was a single dose of MAP0010 low dose delivered by nebulization twice daily for 7 days as per protocol. Treatment 2 was a single dose of Pulmicort Respules® 0.25mg dose delivered by nebulization twice daily for 7 days as per protocol.
|
Treatment 2, Then Treatment 1
n=8 participants at risk
Subjects received Treatment 2 in period 1 followed by a 7 day washout period and then Treatment 1 in period 2. Treatment 1 was a single dose of MAP0010 low dose delivered by nebulization twice daily for 7 days as per protocol. Treatment 2 was a single dose of Pulmicort Respules® 0.25mg dose delivered by nebulization twice daily for 7 days as per protocol.
|
Treatment 3 Then Treatment 4
n=8 participants at risk
Subjects received Treatment 3 in period 1 followed by a 7 day washout period and then Treatment 4 in period 2. Treatment 3 was a single dose of MAP0010 high dose delivered by nebulization twice daily for 7 days as per protocol. Treatment 4 was a single dose of Pulmicort Respules® 0.5mg dose delivered by nebulization twice daily for 7 days as per protocol.
|
Treatment 4 Then Treatment 3
n=8 participants at risk
Subjects received Treatment 4 in period 1 followed by a 7 day washout period and then Treatment 3 in period 2. Treatment 3 was a single dose of MAP0010 high dose delivered by nebulization twice daily for 7 days as per protocol. Treatment 4 was a single dose of Pulmicort Respules® 0.5mg dose delivered by nebulization twice daily for 7 days as per protocol.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
12.5%
1/8
Adverse events are presented by treatment arm, not by individual treatment (intervention) received.
|
0.00%
0/8
Adverse events are presented by treatment arm, not by individual treatment (intervention) received.
|
0.00%
0/8
Adverse events are presented by treatment arm, not by individual treatment (intervention) received.
|
0.00%
0/8
Adverse events are presented by treatment arm, not by individual treatment (intervention) received.
|
|
Gastrointestinal disorders
Nausea
|
12.5%
1/8
Adverse events are presented by treatment arm, not by individual treatment (intervention) received.
|
0.00%
0/8
Adverse events are presented by treatment arm, not by individual treatment (intervention) received.
|
0.00%
0/8
Adverse events are presented by treatment arm, not by individual treatment (intervention) received.
|
0.00%
0/8
Adverse events are presented by treatment arm, not by individual treatment (intervention) received.
|
|
Gastrointestinal disorders
Vomiting
|
12.5%
1/8
Adverse events are presented by treatment arm, not by individual treatment (intervention) received.
|
0.00%
0/8
Adverse events are presented by treatment arm, not by individual treatment (intervention) received.
|
12.5%
1/8
Adverse events are presented by treatment arm, not by individual treatment (intervention) received.
|
0.00%
0/8
Adverse events are presented by treatment arm, not by individual treatment (intervention) received.
|
|
General disorders
Malaise
|
12.5%
1/8
Adverse events are presented by treatment arm, not by individual treatment (intervention) received.
|
0.00%
0/8
Adverse events are presented by treatment arm, not by individual treatment (intervention) received.
|
0.00%
0/8
Adverse events are presented by treatment arm, not by individual treatment (intervention) received.
|
0.00%
0/8
Adverse events are presented by treatment arm, not by individual treatment (intervention) received.
|
|
Infections and infestations
Skin infection
|
0.00%
0/8
Adverse events are presented by treatment arm, not by individual treatment (intervention) received.
|
12.5%
1/8
Adverse events are presented by treatment arm, not by individual treatment (intervention) received.
|
0.00%
0/8
Adverse events are presented by treatment arm, not by individual treatment (intervention) received.
|
0.00%
0/8
Adverse events are presented by treatment arm, not by individual treatment (intervention) received.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/8
Adverse events are presented by treatment arm, not by individual treatment (intervention) received.
|
12.5%
1/8
Adverse events are presented by treatment arm, not by individual treatment (intervention) received.
|
0.00%
0/8
Adverse events are presented by treatment arm, not by individual treatment (intervention) received.
|
0.00%
0/8
Adverse events are presented by treatment arm, not by individual treatment (intervention) received.
|
|
Infections and infestations
Viral infection
|
0.00%
0/8
Adverse events are presented by treatment arm, not by individual treatment (intervention) received.
|
0.00%
0/8
Adverse events are presented by treatment arm, not by individual treatment (intervention) received.
|
12.5%
1/8
Adverse events are presented by treatment arm, not by individual treatment (intervention) received.
|
0.00%
0/8
Adverse events are presented by treatment arm, not by individual treatment (intervention) received.
|
|
Nervous system disorders
Headache
|
12.5%
1/8
Adverse events are presented by treatment arm, not by individual treatment (intervention) received.
|
0.00%
0/8
Adverse events are presented by treatment arm, not by individual treatment (intervention) received.
|
0.00%
0/8
Adverse events are presented by treatment arm, not by individual treatment (intervention) received.
|
12.5%
1/8
Adverse events are presented by treatment arm, not by individual treatment (intervention) received.
|
|
Nervous system disorders
Syncope
|
0.00%
0/8
Adverse events are presented by treatment arm, not by individual treatment (intervention) received.
|
0.00%
0/8
Adverse events are presented by treatment arm, not by individual treatment (intervention) received.
|
0.00%
0/8
Adverse events are presented by treatment arm, not by individual treatment (intervention) received.
|
12.5%
1/8
Adverse events are presented by treatment arm, not by individual treatment (intervention) received.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/8
Adverse events are presented by treatment arm, not by individual treatment (intervention) received.
|
0.00%
0/8
Adverse events are presented by treatment arm, not by individual treatment (intervention) received.
|
12.5%
1/8
Adverse events are presented by treatment arm, not by individual treatment (intervention) received.
|
12.5%
1/8
Adverse events are presented by treatment arm, not by individual treatment (intervention) received.
|
|
Nervous system disorders
Nasal polyps
|
12.5%
1/8
Adverse events are presented by treatment arm, not by individual treatment (intervention) received.
|
0.00%
0/8
Adverse events are presented by treatment arm, not by individual treatment (intervention) received.
|
0.00%
0/8
Adverse events are presented by treatment arm, not by individual treatment (intervention) received.
|
0.00%
0/8
Adverse events are presented by treatment arm, not by individual treatment (intervention) received.
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
12.5%
1/8
Adverse events are presented by treatment arm, not by individual treatment (intervention) received.
|
0.00%
0/8
Adverse events are presented by treatment arm, not by individual treatment (intervention) received.
|
0.00%
0/8
Adverse events are presented by treatment arm, not by individual treatment (intervention) received.
|
0.00%
0/8
Adverse events are presented by treatment arm, not by individual treatment (intervention) received.
|
Additional Information
VP, Scientific Affairs
MAP Pharmaceuticals Inc., a wholly owned subsidiary of Allergan
Phone: 650-386-3100
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
- Publication restrictions are in place
Restriction type: OTHER